Bioavailability of Vitamin D(25(OH)D) and Omega-3 Fatty Acid (DHA) Enhanced Chicken

Sponsor

Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05248737

Collaborator

(none)

Enrollment

Location

24.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the research is to evaluate if chicken that is fed a diet that contains omega-3 fatty acids (DHA/EPA), vitamin D (as 25(OH)D) or both nutrients provides additional health benefits by improving the status of omega-3 fatty acids and 25(OH)D in healthy adults who eat this bioenhanced chicken.

Condition or Disease	Intervention/Treatment	Phase
Nutrition, Healthy	Dietary Supplement: DHA/EPA bioenhanced chicken Dietary Supplement: 25(OH)D bioenhanced chicken

Detailed Description

The 2015-2020 Dietary Guidelines advocate intake of lean proteins (such as chicken and fish) while limiting intake of saturated fat. Chicken contains similar protein to beef or pork but has less saturated fat. However, chicken, like other terrestrial meats, has little omega-3 polyunsaturated fatty acids such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) and relatively little vitamin D. Vitamin D insufficiency is common in the US and globally, and has been linked to a number of adverse health outcomes. Vitamin D is ingested primarily from fortified dairy products, but recent animal studies have increased the D content of pork and beef, and the DHA content of chicken. Moreover, sunlight exposure alone can enhance the 25(OH)D content of chicken. Notably, supplemental 25(OH)D is more effective than vitamin D at improving vitamin D status in humans, but little is known about the bioavailability of 25(OH)D or DHA/EPA enhanced chicken (muscle).

Study Design

Study Type:

Observational

Anticipated Enrollment :

84 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Empowering and Transforming the US Broiler Production for Growth, Profit and Sustainability

Actual Study Start Date :

Dec 4, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group 1 - DHA/EPA bioenhanced poultry (n=24) Participants will be asked to consume two meals of chicken, one meal will contain chicken that has been fed omega-3 fatty acids so the chicken contains omega 3 (DHA/EPA) fatty acids and the other meal will consist of non enhanced chicken and a DHA supplement. Each participant will be asked to eat both of these forms of chicken in random order. Each study is expected to take 9-hours and the two visits will be separated by a period of two weeks. A total of 5 blood samples will be collected over a 9-h period.	Dietary Supplement: DHA/EPA bioenhanced chicken Chicken fed on a high DHA/EPA diet
Group 2 - 25(OH)D bioenhanced poultry (n=36) Participants will be asked to consume 1 serving of 25-hydroxyvitamin D (25(OH)D enhanced chicken or non-fortified chicken that does not contain additional 25(OH)D and a vitamin D supplement every day for 21 days. Your participation in the study is expected to last 3 weeks. On Monday-Friday you will be asked to eat lunch in the HMRU on the Cornell campus. On weekends you will be given packaged chicken to eat at home. At 4 timepoints over the 3-week study, a blood draw will be collected to measure vitamin D status and other nutrients (such as hemoglobin, hematocrit, and concentrations of omega-3 fatty acids). Each blood draw visit should last about 30 minutes. The total time needed to complete study visits in the HMRU is 10 hours over the 21-day period.	Dietary Supplement: 25(OH)D bioenhanced chicken Chicken fed on a high 25(OH)D diet
Group 3 - DHA/EPA and 25(OH)D bioenhanced poultry (n=24) Participants will be asked to consume chicken that contains both omega3 (DHA/EPA) fatty acids and vitamin D (25(OH)D) for a 3week period. On the first day, you will be asked to spend around 9h in the HMRU, and will be fed a breakfast containing this chicken. A total of 5 blood samples will be collected over the 9h period. You will be asked to stay in the HMRU for this 9h study and will be fed breakfast, lunch and dinner. For the next 3w you will be asked to eat this chicken at lunch in the HMRU on the Cornell campus on weekdays (Monday-Friday). On weekends you will be given two packaged frozen chicken servings to eat at home (one serving per day). At 4 timepoints over the 3-week study, a blood draw will be collected to measure (25(OH)D) status and other nutrients (such as hemoglobin, hematocrit, and concentrations of omega-3 fatty acids). Each blood draw visit to the HMRU should last about 30 minutes. The time needed to complete this study in the HMRU is 10 hours over the 3w period.	Dietary Supplement: DHA/EPA bioenhanced chicken Chicken fed on a high DHA/EPA diet Dietary Supplement: 25(OH)D bioenhanced chicken Chicken fed on a high 25(OH)D diet

Arm

Intervention/Treatment

Group 1 - DHA/EPA bioenhanced poultry (n=24)

Participants will be asked to consume two meals of chicken, one meal will contain chicken that has been fed omega-3 fatty acids so the chicken contains omega 3 (DHA/EPA) fatty acids and the other meal will consist of non enhanced chicken and a DHA supplement. Each participant will be asked to eat both of these forms of chicken in random order. Each study is expected to take 9-hours and the two visits will be separated by a period of two weeks. A total of 5 blood samples will be collected over a 9-h period.

Dietary Supplement: DHA/EPA bioenhanced chicken

Chicken fed on a high DHA/EPA diet

Group 2 - 25(OH)D bioenhanced poultry (n=36)

Participants will be asked to consume 1 serving of 25-hydroxyvitamin D (25(OH)D enhanced chicken or non-fortified chicken that does not contain additional 25(OH)D and a vitamin D supplement every day for 21 days. Your participation in the study is expected to last 3 weeks. On Monday-Friday you will be asked to eat lunch in the HMRU on the Cornell campus. On weekends you will be given packaged chicken to eat at home. At 4 timepoints over the 3-week study, a blood draw will be collected to measure vitamin D status and other nutrients (such as hemoglobin, hematocrit, and concentrations of omega-3 fatty acids). Each blood draw visit should last about 30 minutes. The total time needed to complete study visits in the HMRU is 10 hours over the 21-day period.

Dietary Supplement: 25(OH)D bioenhanced chicken

Chicken fed on a high 25(OH)D diet

Group 3 - DHA/EPA and 25(OH)D bioenhanced poultry (n=24)

Participants will be asked to consume chicken that contains both omega3 (DHA/EPA) fatty acids and vitamin D (25(OH)D) for a 3week period. On the first day, you will be asked to spend around 9h in the HMRU, and will be fed a breakfast containing this chicken. A total of 5 blood samples will be collected over the 9h period. You will be asked to stay in the HMRU for this 9h study and will be fed breakfast, lunch and dinner. For the next 3w you will be asked to eat this chicken at lunch in the HMRU on the Cornell campus on weekdays (Monday-Friday). On weekends you will be given two packaged frozen chicken servings to eat at home (one serving per day). At 4 timepoints over the 3-week study, a blood draw will be collected to measure (25(OH)D) status and other nutrients (such as hemoglobin, hematocrit, and concentrations of omega-3 fatty acids). Each blood draw visit to the HMRU should last about 30 minutes. The time needed to complete this study in the HMRU is 10 hours over the 3w period.

Dietary Supplement: DHA/EPA bioenhanced chicken

Chicken fed on a high DHA/EPA diet

Dietary Supplement: 25(OH)D bioenhanced chicken

Chicken fed on a high 25(OH)D diet

Outcome Measures

Primary Outcome Measures

Concentration of plasma DHA concentrations [Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal]
Measuring plasma DHA concentration across different time points to assess DHA bioavailability and absorption
Concentration of plasma 25(OH)D concentrations [Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal]
Measuring plasma 25(OH)D concentration across different time points to assess 25(OH)D bioavailability and absorption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy adults
Non-smoking
Age between 18- 24 yo
Females: premenopausal and not pregnant or lactating
Body mass index (BMI) between 18 - 30 kg/m2.
No preexisting medical complications (such as eating disorders, gastrointestinal disorders, malabsorption diseases, or taking medications known to influence iron homeostasis)

Exclusion Criteria:

BMI <18 or > 30 kg/m2,
Age <18 y or > 50y,
Smoking
Pregnancy, lactating
Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/medication use of medications known to impact DHA/EPA or Vitamin D 25(OH)D absorption
Take vitamin and mineral supplementations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Metabolic Research Unit	Ithaca	New York	United States	14850

Sponsors and Collaborators

Cornell University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cornell University

ClinicalTrials.gov Identifier:

NCT05248737

Other Study ID Numbers:

1904008786

First Posted:

Feb 21, 2022

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cornell University

Vitamin D

Omega-3 fatty acids

Study Results

No Results Posted as of Jun 6, 2022